Penile prosthesis with improved tubing junction

ABSTRACT

The present disclosure relates to penile implants that are easier to implant and reduce trauma because they provide for a smaller effective width during implantation, after implantation, or both. The present disclosure also provides for a shorter tubing junction while reducing effective width, further reducing trauma to the body. In a first aspect, the penile implant includes a tubing junction that is smaller in effective diameter while implanted in the body. The penile implant includes an axially extending cylinder having an inflation chamber and a rear tip. The cylinder also includes a tubing junction disposed between the inflation chamber and rear tip and extending from the cylinder. The tubing junction includes a bore in fluid communication with the inflation chamber. In one example, this bore is in the strain relief of the tubing junction. The bore is configured to include a compound curve. In another aspect, the penile implant includes a tubing junction that can assume a smaller effective diameter while being implanted into the body. The surgeon is able to press the tubing against the cylinder than the related art to reduce the effective area of the penile implant. This penile implant includes a cylinder having an inflation chamber and a rear tip. A tubing junction is disposed between the inflation chamber and the rear tip. The tubing junction includes a strain relief that extends from the cylinder and forms an acute area proximate the intersection of the cylinder and the strain relief. The acute area includes a keyhole.

BACKGROUND

The present disclosure relates to medical devices used in implantsurgery. More specifically, the present disclosure relates to aninflatable penile prosthesis, or penile implant.

The study of impotence has recently become center stage in the field ofmedicine. In the early 1970's, the conventional view was that ninetypercent of impotence cases were psychologically based, whereas only tenpercent of the cases were caused by a physical condition. Today, doctorsand scientists understand that the overwhelming majority of cases arecaused by a physical condition. Accordingly, more and more resources arepoured into the study of and treatment for impotence. According to arecent study, fifty-two percent of men between the ages of forty andseventy self-reported that they suffer from some type of erectiledysfunction. Another study estimated that over thirty million Americanmen and their partners suffer from erectile dysfunction.

Advertisements for pharmaceutical treatments for impotence have becomeubiquitous, and include endorsements from celebrities that suffer fromerectile dysfunction. More and more men and their partners now areseeking treatment for impotence. In the recent past, it was estimatedthat only one in twenty sufferers of erectile dysfunction soughttreatment from their doctors. Pharmaceutical treatments are successfulfor only a subset of impotence sufferers. More invasive treatments arenecessary for many men. These treatments include injection therapy,vacuum devices and penile prosthesis.

For many impotence sufferers, the penile implant is the only solution torestore a happy and healthy sex life. The penile implant has been usedfor decades and provides a selected and reliable erection. The penileimplant often includes a pair of cylinders. In some instances, thesecylinders are inflatable, and are connected to a fluid-filled reservoirwith a pump and valve assembly. The two cylinders are normally implantedinto the corpus cavernosae of the patient's penis and the reservoir istypically implanted into the patient's abdomen. The pump assembly isimplanted in the scrotum. During use, the patient actuates the pump andfluid is transferred from the reservoir through the pump and into thecylinders. This results in the inflation of the cylinders and producesrigidity for a normal erection. Then, when the patient desires todeflate the cylinders, a valve assembly within the pump is actuated in amanner such that the fluid in the cylinders is released back into thereservoir. This deflation returns the penis to a flaccid state.

A type of inflatable penile implant includes a cylinder having aninflation chamber side that is disposed within the penis (distal corpuscavernosae) and rear tip side that is disposed within the body (proximalcorpus cavernosae). The penile implant includes a remote pump assemblythat is connected via tubing to the cylinder. The tubing is connected tothe cylinder at a tubing junction. Typically, this tubing junction islocated near the interface between the inflation chamber and the reartip. The tubing junction includes a strain relief that extends from thecylinder like a branch from a tree trunk. The tubing is inserted intothe strain relief. In prior art examples, such as those in U.S. Pat.Nos. 4,651,721 and 5,167,611, among others, show a straight boreextending through the strain relief and into the inflation chamber.Fluid is transferred from the pump assembly, through the tubing, andinto the inflation chamber.

The penile implant is an invasive treatment and requires a delicate andpainful implant surgery to install. To reach the corpus cavernosum andimplant the cylinders, the surgeon will first make an incision at thebase of the penis, such as where it meets the scrotum. The patient isprepared for the cylinder after the surgeon has dilated each corpuscavernosum to create space for the cylinders. The distal end of thecylinder, i.e., the inflation chamber, is inserted into the corpuscavernosum. The proximal end of the cylinder, i.e., the rear tip andtubing junction, is inserted back into the body toward the pubic bone.

The tubing junction, and particularly the strain relief, increases theeffective width, or effective diameter, of the cylinder. This increasedwidth can create problems for both the surgeon and the patient duringsurgery. Some physicians have difficulty dilating the proximal corporalbody sufficiently to accept the proximal end of the cylinder. And theadded effective diameter of the tubing junction sometimes requires thatthe surgeon force the device through pelvic tissue, such as severefibrotic tissue in some patients. This can make proper insertion andplacement more difficult than if the cylinder were easily inserted, andcan require further cutting and trauma. Further, the added effectivewidth causes an increase in trauma to what is otherwise a sensitive areafor the patient, which can require longer healing times.

SUMMARY

The present disclosure relates to penile implants that are easier toimplant and reduce trauma because they provide for a smaller effectivewidth during implantation, after implantation, or both. The presentdisclosure also provides for a shorter tubing junction while reducingeffective width, further reducing trauma to the body.

In the first aspect, the present disclosure relates to a penile implantthat includes a tubing junction that is smaller in effective diameterwhile implanted in the body. A penile implant includes an axiallyextending cylinder having an inflation chamber and a rear tip. Thecylinder also includes a tubing junction disposed between the inflationchamber and rear tip and extending from the cylinder. The tubingjunction includes a bore in fluid communication with the inflationchamber. In one example, this bore is in the strain relief of the tubingjunction. The bore is configured to include a compound curve. Thecompound curve in the bore permits the strain relief to lay flatteragainst the cylinder than a straight bore or even a bore with a“hairpin” curve.

In another aspect, the present disclosure relates to a penile implantthat includes a tubing junction that can assume a smaller effectivediameter while being implanted into the body. Specifically, the surgeonis able to press the tubing against the cylinder than the related art toreduce the effective area of the penile implant. This penile implantincludes a cylinder having an inflation chamber and a rear tip. A tubingjunction is disposed between the inflation chamber and the rear tip. Thetubing junction includes a strain relief that extends from the cylinderand forms an acute area proximate the intersection of the cylinder andthe strain relief. The acute area includes a keyhole. The keyholepermits the strain relief to lie closer to the cylinder without causingdamage to the tubing, strain relief, or other parts of the prosthesis.

The present disclosure provides many advantages, among which two arelisted here. These two aspects have been demonstrated to provide acylinder having an advantageously smaller effective diameter during orafter implantation than the related art. The tubing junction with a boreconfigured to include a curve having a compound angle providesnoticeable advantages both during and after implantation. One examplehas been demonstrated to be at least approximately fifteen percentsmaller in effective diameter over popular products of the related art.Additionally, the aspect with the keyhole has been demonstrated topermit the strain relief to lie flat, i.e., zero degrees, against thecylinder, during implantation of the device. Other advantages willbecome apparent to those skilled in the art.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic side view of a penile prosthesis implanted in apatient.

FIG. 2 is a perspective view of the penile prosthesis of FIG. 1.

FIG. 3 is a side sectioned view of a portion of the penile implant ofFIG. 2.

FIG. 4 is an enlarged side sectioned view of the portion of the penileimplant of FIG. 3.

DESCRIPTION

This disclosure relates to an improved penile implant. The disclosure,including the figures, describes the improved penile implant withreference to several illustrative examples. Other examples arecontemplated and are mentioned below or are otherwise imaginable tosomeone skilled in the art. The scope of the invention is not limited tothe few examples, i.e., the described embodiments of the invention.Rather, the scope of the invention is defined by reference to theappended claims. Changes can be made to the examples, includingalternative designs not disclosed, and still be within the scope of theclaims.

FIG. 1 is a schematic side view of a penile prosthesis 10 implanted in apatient. The prosthesis 10 includes a pair of cylinders, one of which isshown as cylinder 12, implanted in a penis 14. The prosthesis can alsoinclude a pump 16, often implanted into the patient's scrotum 18. Thetubing 20 attaches the pump 16 to the cylinders such that the pump 16 isin fluid communication with the cylinder 12. In still an alternativeexample, the pump 16 can be in fluid communication with a fluidreservoir (not shown) that is often implanted into the patient'sabdomen. The prosthesis including cylinders, pump, and fluid reservoiris referred to as a three-piece device. In the present example, theprosthesis 10 includes a pair of cylinders 12 and a pump 16 and is knownas a two-piece device. The disclosure is directed to devices including atubing attached to the cylinders, and thus includes both two andthree-piece devices.

The cylinder 12 includes an inflation chamber 22 that is disposed withinthe penis 14. The distal end 24 of the cylinder 12 is disposed withinthe crown 26 portion of the penis 14. The cylinder also includes aproximal end 28 that often includes the tubing junction 30, i.e., thestructural portion of the cylinder 12 connected to the tubing 20, andthe rear tip 32 of the cylinder 12. The proximal end 28 is typicallyimplanted into the patient's pubic region 34 with the rear tip 32proximate the pubic bone 36.

The prosthesis 10 is shown by itself in FIG. 2. The prosthesis includesa pair of cylinders 12 connected by tubing 20 to a pump 16. Like partsof each cylinder are given the same reference number. Accordingly, theprosthesis 10 is a two-piece device. The prosthesis includes twocylinders 12, one for each side of the penis. Each cylinder includes adistal end 24 having a distal tip 37, an inflation chamber 22 and aproximal end 28 including a tubing junction 30, a rear tip 32 and a rearend 39. The pump 16 serves to inflate both cylinders 12. In the case ofa three-piece device, typically one fluid reservoir is connected influid communication with the pump.

In order to implant the cylinders 12, the surgeon first prepares thepatient. The surgeon often makes an incision in the penoscrotal region38, i.e., where the base of the penis 14 meets with the top of thescrotum 18. From the penoscrotal incision, the surgeon will dilate thepatient's corpus cavernosae 40 to prepare the patient to receive thecylinders 12. The corpus cavernosum is one of two parallel columns oferectile tissue forming the dorsal part of the body of the penis 14,i.e., two slender columns that extend substantially the length of thepenis. The surgeon will also dilate two regions of the pubic area(proximal corpora cavernosae) to prepare the patient to receive theproximal ends 28. The surgeon will measure the length of the proximaland distal corpora cavernosae from the incision and the dilated regionof the pubic area to determine an appropriate size of the cylinders 12to implant.

After the patient is prepared, the prosthesis 10 is implanted into thepatient. The distal tip 37 of each cylinder often is attached to asuture. The other end of the suture is often then attached to a Keithneedle. The Keith needle is inserted into the incision and into thedilated corpus cavernosum. The Keith needle is then forced through thecrown of the penis. The surgeon tugs on the suture to pull the cylinderinto the corpus cavernosum. This is done for each cylinder. Once theinflation chamber 22 is in place, the surgeon removes the suture fromthe distal end 37. The surgeon then inserts the proximal end 28. Thesurgeon inserts the rear ends 39 into the incision and forces theproximal ends 28 toward the pubic bone 36 until the cylinders are inplace.

FIG. 3 shows a side sectioned view of one of the cylinders 12 and aportion of its associated tubing 20. The cylinder 12 includes an axis42. The distal end 24 and proximal end 28 are disposed along the axis42.

The distal end 24 forms part of the inflation chamber 22. The distal end24 is generally solid but can include a hole 44 that is adapted toreceive the suture described above. In the example, the distal end 24 isconstructed from a silicone rubber or silicone elastomer. The inflationchamber 22 in the example includes a multilayer tube. The exampleincludes three layers. The innermost layer is an extruded siliconeelastomer, the middle layer is a distensible fabric such as a polyesterand spandex blend, and the outer layer is also an extruded silicone.

The layers can include a coating such as parylene. Parylene coating is amedical grade polymer intended to reduce friction-based wearoccurrences. Parylene can be applied to the layers as is known in theart.

The proximal end 28 includes the rear tip 32 and the tubing junction 30.In the example, the rear tip 32 is solid and formed from a siliconerubber or silicone elastomer. The rear tip can also include bariumsulfate, so that it can be easily visible in an X-Ray of the region. Thebarium sulfate can also be added to other parts of the prosthesis forthe same purpose. Other radio-opaque substances or markers can be used,such as aluminum oxide, iridium, or others. The section of the rear tip32 near the rear end 39 can be adapted to receive a rear tip extender asis known in the art. In one example, the approximate length of the reartip 32, from the tubing junction 30 to the rear end 39, is threecentimeters, which has been determined to be an advantageous length. Incases where this length is not long enough, rear tip extenders are usedfor the proper fit.

The tubing junction 30 is disposed between the inflation chamber 22 andthe rear tip 32. The tubing junction includes a strain relief 46branching from the axially extending cylinder. The strain relief 46includes a bore 48 extending into the axially extending cylinder into aflared opening 50 in fluid communication with the inflation chamber 22.In the example, a silicone rubber tube, or input tubing 52 portion oftubing 20, is disposed within the bore 48 up to the flared opening 50.The tubing 52 is attached to the strain relief 46 and is commonly knownas kink resistant tubing, which can include a nylon suture filament toreduce the chance of the tube kinking after implant. The strain reliefis generally more rigid than the tubing 20, and prevents the tubing 20from over flexing against the tubing junction 32, which can damage thetubing or cause kinking and occluding flow.

FIG. 4 is an enlarged view of the tubing junction 30 shown in FIG. 3.The tubing junction 30 includes a keyhole 60 formed in the acute area62, i.e., the area between the strain relief and the axially extendingcylinder. The keyhole 60 in the example is a circular cutout of materialforming indents in the axially extending cylinder 12 and the strainrelief 46. Indents in the cylinder 12, strain relief 46, or both,provide the ability for the strain relief 46 to be flexed against thecylinder 12 in a smaller effective diameter than without the keyhole.The surgeon squeezes the strain relief and tubing against the cylinder,and the cylinder will have a smaller effective diameter than without thekeyhole, so that the proximal end can be implanted easier than before orinto a less dilated region of the body.

The keyhole 60 in the example is disposed in the acute area directlywhere the strain relief joins the cylinder. The cylinder proximate theacute area does not continue with a generally smooth profile into thestrain relief, but instead includes an indent causing a widening of theacute area. Similarly, in the example, the strain relief proximate theacute area does not include a smooth profile into the cylinder, butinstead also includes an indent causing a further widening of the acutearea. This widening of the acute area permits the strain relief to foldagainst the cylinder with a smaller effective diameter than without thekeyhole.

The keyhole 60 is subject to many variations. For example, the keyhole60 need not be circular, but could be oval or any other suitable shape.The keyhole preferably includes indents in both the strain relief 46 andcylinder 12 in the acute area 62. Indents, however, could be provided ineither the strain relief or the cylinder.

The bore 48 in the strain relief 46 follows a curve having a compoundangle (or “compound curve” as may be used here) that also provides for alower effective diameter. In contrast to the keyhole, the compound angleprovides the cylinder with a lower effective diameter when the strainrelief 46 is not urged against the cylinder. Accordingly, a prosthesiswith both a keyhole and a compound curve in the strain relief providesthe surgeon with an ease of insertion and the patient with a lessinvasive prosthesis. The compound curve does not provide impediments toinflating or deflating the inflation chamber.

The compound curve in the example has at least one bend in the strainrelief bore 48. One way to describe the curve having a compound angle isthat the path of the bore in the strain relief has at least two angleswith respect to the axis 42 of the cylinder. Another way to describe thecompound curve is that the bore follows more than one radius ofcurvature in the strain relief. In the example, the bore initiallyextends from the cylinder, at region 70, at an angle of 43 degreesbetween the axis 64 of region 70 from the axis 42 of the cylinder. Atregion 72, the angle between the axis 66 of region 72 and the axis 42 ofthe cylinder is only 22 degrees. In other words, the radius of curvatureof the bore at region 70 is less than the radius of curvature of region72.

In the example, the bore follows a smooth curvilinear path. The changesin the radius of curvature or angle from the axis are subtle and notabrupt. The acute angles formed in region 70 and 72 are separated bytransition region 74. In some examples, the compound curve need notinclude transition region 74, and the change in angles is abrupt. Forthe purposes of this disclosure, such abrupt changes are also consideredcompound curves. The examples show strain relief having two angles orradii of curvature. More angles or radii of curvature are possible. Thetwo angle or radii construction having acute angles of 43 and 22 degreeshas been determined to optimize the need for a low profile or effectivediameter of the cylinder and for manufacturing efficiency.

The application of a compound curve strain relief also permits greaterflexibility in design of the prosthesis. The bore configured to includea compound curve permits a low profile and a shorter tubing junctionlength, as measured along the axis of the cylinder. With a shorterlength of tubing junction, the length of the rear tip 32 and inflationchamber 22 can be optimized, as understood by designers. For example, ashorter tubing junction 30 can permit a longer rear tip, and the surgeonwill not need to dilate the body to make room for the strain relief.

The present invention has now been described with reference to severalembodiments. The foregoing detailed description and examples have beengiven for clarity of understanding only. Those skilled in the art willrecognize that many changes can be made in the described embodimentswithout departing from the scope and spirit of the invention. Thus, thescope of the present invention should not be limited to the exactdetails and structures described herein, but rather by the appendedclaims and equivalents.

1. A penile implant, comprising: a pair of cylinders each having aninflation chamber and a rear tip; and a tubing junction disposed betweenthe inflation chamber and rear tip and extending from each of thecylinders, the tubing junction having a bore in fluid communication withthe inflation chamber; wherein the bore is configured to include a curvehaving a compound angle.
 2. The penile implant of claim 1 wherein thetubing junction is adapted to receive a tubing wherein the tubing is influid communication with the inflation chamber.
 3. The penile implant ofclaim 1 wherein the tubing junction includes a strain relief.
 4. Thepenile implant of claim 3 wherein the strain relief is adapted toreceive a tubing.
 5. The penile implant of claim 1 wherein the curveincludes a path having two radii of curvature.
 6. The penile implant ofclaim 1 wherein the curve includes a path having a transition region.7-12. (canceled)
 13. The penile implant of claim 1 wherein the tubingjunction is in fluid communication with a pump.
 14. The penile implantof claim 13 wherein the pump is in fluid communication with a fluidreservoir.